Quantitative Pharmacology-Based Dose Adjustment Protocol in Postoperative Thyroid Cancer Patients

Completed

Conditions studied: Thyroid and Other Endocrine Gland Carcinoma in Situ

In brief

Through pharmacometric approaches-including modeling, mathematics, and statistics-this work aims to refine the levothyroxine sodium tablet (brand name: Euthyrox) dosing strategy in post-thyroidectomy cancer patients, enabling individualized precision dosing to minimize side effects and maximize therapeutic outcomes.

Key facts

Study ID

NCT07752277

Run by

Zhejiang Provincial People's Hospital

People needed

124

Starts

2022-12-06

Expected to finish

2026-02-23

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1.Aged 18-65 years (inclusive), any gender; 2.Able to fully understand and voluntarily sign the informed consent form; 3.Patients with histologically or cytologically confirmed advanced/metastatic thyroid cancer who are treatment-naïve and require total or near-total thyroidectomy; 4.ECOG performance status ≤ 2; 5.No obvious contraindications to surgery; 6.Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females, with a body mass index (BMI) of 19.0-26.0 kg/m² (inclusive of 19.0 and 26.0); 7.Subjects with regular daily routines, capable of maintaining good communication with the investigator and complying with all clinical trial requirements, and willing and able to adhere to the scheduled protocol visits, treatment plan, and laboratory assessments; 8.Patients must have adequate baseline organ function at the screening visit, including local laboratory values meeting the inclusion criteria as specified below.

You may not qualify if…

• 1.Thyroid cancer patients whose thyroidectomy does not meet the criteria for total or near-total resection; 2.Patients with prior treatment for thyroid cancer (including surgery and/or medication); 3.Patients who have undergone major surgery (including radiosurgery) or experienced significant traumatic injury within 2 weeks prior to randomization; 4.History of other malignancies within <3 years prior to the initiation of study treatment; 5.Subjects with a known history of positive human immunodeficiency virus (HIV) testing; 6.Known active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) (chronic or resolved HBV and HCV infections are permitted); 7.Patients with congenital or acquired immunodeficiency; 8.History of clinically significant drug allergy or atopic allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.), or known hypersensitivity to Euthyrox (levothyroxine sodium) or any of its excipients; 9.Pregnant or lactating females.

Where it is running

• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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